# K261002: Pectus Blu System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: Jun 2, 2026 after 68 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K972420 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241709: Pectus Blu Support Bar System, Biomet Microfixation (2024)

## Indications for use
The Pectus Blu System is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

Source page: https://510kreport.com/device/K261002
Methodology: https://510kreport.com/methodology